# K023203: Osstaple

- Pathway: 510(k) (Special)
- Applicant: Biomedical Ent., Inc.
- Decided: Oct 17, 2002 after 22 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902307 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993714: Memograph Staple, Warm System, Biomedical Ent., Inc. (2000) Summary page 2.
- K001219: Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple  System, Biomedical Ent., Inc. (2000) Summary page 2.
- K001353: Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for the Memograph Staple System, Biomedical Ent., Inc. (2001) Summary page 2.
- K001354: Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System, Biomedical Ent., Inc. (2001) Summary page 2.

## Indications for use
The Menogrqh@Staple is intended for: 1) hand and foot bone fragment and osteotomy fixation and joint arlhrodesis, 2) fixalion of proximal tibial metaphysic osteotomy, and 3) fixation of soft tissue to bone such as anterior cniciate reconstroction-

Source page: https://510kreport.com/device/K023203
Methodology: https://510kreport.com/methodology